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Class 4 Medicines Notification, Star Pharmaceuticals Limited, Diflucan Oral Suspension 40mg/ml, EL(24)A36

Medicines Healthcare Products Regulatory Agency

August 12
10:00 2024

DMRC reference number

DMRC-31353215

Company name

Star Pharmaceuticals Limited

Diflucan Oral Suspension 40mg/ml, PLPI 20636/3070

SNOMED Code

N/A

Batch Number Expiry Date Pack Size First Distributed
B861104 09/2026 35 ml 20/05/2024
B694104 12/2024 35 ml 11/06/2024

Active Pharmaceutical Ingredient: fluconazole

Brief description of the problem

Star Pharmaceuticals Limited has informed the MHRA that an error has been identified in the Patient Information Leaflet (PIL) for two batches of Diflucan Oral Suspension 40mg/ml.

Section 6 of the PIL states 50mg of fluconazole per 5ml instead of 200mg of fluconazole per 5ml. The other sections of the PIL and product information state the correct strength of 200mg of fluconazole per 5ml.

Advice for healthcare professionals

There is no risk to product quality because of this issue, therefore the affected batch is not being recalled.Healthcare professionals should continue to use the product as normal but be aware of the typographical error highlighted in this notification. Star Pharmaceuticals Limited have also confirmed that they have identified all customers who have been supplied with this product and will initiate direct contact with the relevant customers.

Advice for patients

No further action is required by patients. If you have received or receive the impacted batches of Diflucan Oral Suspension 40mg/ml listed in this notification, please continue to take your medicine as prescribed by your doctor and as per the dispensing label. If you have concerns about a medicine you may be using, please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via theMHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

For stock control enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 4 Medicines Notification, Star Pharmaceuticals Limited, Diflucan Oral Suspension 40mg/ml, EL(24)A36

Updates to this page

Published 12 August 2024

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